• Title/Summary/Keyword: Drug safety assessment

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Assessment of Estimated Daily Intake of Sorbic Acid and Benzoic Acid in the Korean Population (한국인의 소르빈산 및 안식향산 섭취수준 평가)

  • Lee, Kyung-Hyun;Kim, Ae-Young;Choi, Sung-Hee;Lim, Ho-Soo;Choi, Jae-Chun;Kim, Mi-Hye;Kim, So-Hee;Ha, Sang-Do
    • Journal of Food Hygiene and Safety
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    • v.28 no.4
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    • pp.293-298
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    • 2013
  • In this study, sorbic acids and benzoic acids frequently used in foods retailed in Korea were monitored and their estimated daily intakes were assessed for a purpose to ensure food additives safety management. The estimated daily intakes were calculated by categorizing the assessment items into the national average, by gender, by age and the high intake ($95^{th}$) groups based on concentrations of preservatives in foods as well as national health and nutrition survey data. The calculations were then compared with the ADI of the JECFA and the possibility of risk to be imposed on the people was examined. The results indicated that the estimated daily average intakes of preservatives were $221.60{\mu}g/kg{\cdot}bw/day$ of sorbic acids and $27.30{\mu}g/kg{\cdot}bw/day$ of benzoic acids. Compared to the ADI, the intake levels were 0.89 and 0.55% respectively, which were in a safe range. The estimated daily intakes of sorbic acids and benzoic acids in the high intake group ($95^{th}$) were $1140.27{\mu}g/kg{\cdot}bw/day$ and $194.95{\mu}g/kg{\cdot}bw/day$, which were 4.56% and 3.90% of the ADI (%) respectively, indicating that the intake levels of sorbic acids and benzoic acids in the high intake group were within a safe range. As for gender difference, the amount of benzoic acids intake was slightly larger in men than in women. However, gender differences were not observed in terms of the intake of sorbic acids. In terms of the levels of intake by age, the rates were found to be in the range of 0.52-2.10% for sorbic acids and 0.15-1.23% for benzoic acids. Therefore, the levels of sorbic acids and benzoic acids intakes were found not to exceed the ADI in all groups, and thus were within the safe ranges.

Standard Methods for the Detection and Assessment of Safety in Milk and Dairy Products in Korea (우유 및 유제품의 안전성 평가를 위한 병원성미생물 검사법)

  • Kim, Hyoun-Wook;Seol, Kuk-Hwan;Ham, Jun-Sang;Jang, Ae-Ra;Kim, Dong-Hun;Oh, Mi-Hwa
    • Journal of Dairy Science and Biotechnology
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    • v.29 no.2
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    • pp.59-68
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    • 2011
  • In Korea, there are a couple of risk assessment organizations: The Animal Plant and Fisheries Quarantine and Inspection Agency(QIA) and the Korea Food and Drug Administration (KFDA). The major food laws include the Food Sanitation Act (FSA), the Livestock Product Processing Act (LPPA), and the Agricultural Products Quality Control Act (APQCA). Milk and dairy products are mostly controlled by the Food Sanitation Act and the Livestock Product Processing Act. This study was carried out to estimate the current standard methods of foodborne pathogens for dairy products, comparing the Livestock Products Processing Act with the Food Sanitation Act. The standard methods of foodborne pathogens for dairy products are composed by growth culture, isolation culture, and identification, however, standard methods of QIA and KFDA are different at the using of medium and inspection stage. Therefore, consolidation of risk management and risk assessment methods are regarded important to provide safe dairy products to consumer.

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Estimation of Amount and Frequency of Consumption of 50 Domestic Livestock and Processed Livestock Products (국내 50가지 축산물 및 축산가공 식품의 섭취량 및 섭취빈도 조사)

  • Park, Jin Hwa;Cho, Joon Il;Joo, In Sun;Heo, Jin Jae;Yoon, Ki Sun
    • Journal of the Korean Society of Food Science and Nutrition
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    • v.45 no.8
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    • pp.1177-1191
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    • 2016
  • Estimation of food consumption details, such as portion size and frequency of consumption, is needed for exposure assessment step in microbiological risk assessment. This study investigated the amounts and frequencies of 50 kinds of consumed livestock products. A quantitative survey was performed by trained interviewers in face-to-face interviews with 1,500 adults aged over 19, who were randomly selected from seven major provinces in Korea. Respondents received a picture of one serving size for each of the 50 livestock products, including meats, processed meat products, milk and dairy products, and eggs and processed egg products. A t-test and general linear model were carried out using SPSS statistics. The most important factor affecting consumption of livestock products was residence area. The most frequently consumed food was milk (2.6 times/week), followed by pork (1.4 times/week), liquid yogurt (1.3 times/week), rolled omelet (1.2 times/week), semisolid yogurt (1.0 times/week), steamed egg (1.0 times/week), ice cream (0.9 times/week), chicken (0.8 times/week), low fat milk (0.7 times/week), and beef (0.6 times/week). In the case of consumption amount, people living in a city consumed meat (beef, pork, chicken, and duck) 1.5 times more than those living in a village, whereas milk and dairy products and eggs and processed egg products were consumed more frequently by people living in a town. When people eat meat, they consume twice the amount of one serving size. Students consumed livestock and processed livestock products more frequently with greater portions all at once. People living in Seoul, Incheon/Gyeonggi, and Busan/Ulsan/Gyeongnam consumed livestock products more frequently in large amounts. Data from this study can be used for risk assessment of livestock and processed livestock products as well as education for safe consumption of livestock products.

Evaluation of the Perceived Performance on Sanitary Management of Cooked Foods in Foodbanks (푸드뱅크 조리기탁식품의 안전성 확보를 위한 위생관리 실태 평가)

  • Hwang Yun-Kyung;Park Ki-Hwan;Ryu Kyung
    • Korean Journal of Community Nutrition
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    • v.11 no.2
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    • pp.240-252
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    • 2006
  • A survey was implemented to suggest basic data for assuring the safety of cooked foods in foodbank operations. A questionnaire consisted of total 48 items including general characteristics, basic inputs and perceived importance/performance of sanitary management. One hundred twenty-eight responses among the 267 nationwide foodbanks were used for the statistical analysis. About forty-one percent of foodbanks was operated a period of 1-3 years and 43.0% of them were managed by social welfare organizations. The number of staff was only 0.5 person per operation with the whole responsibility and 1.0 with additional work, and thus most of the work was managed by volunteers. Job satisfaction was shown to be moderate and was affected by specialty and salary mostly. The facilities and equipment in foodbanks were not enough to operate and freezers/refrigerators were the top priority to supplement. Most of the respondents attended a nationwide level sanitary education program (79.7%); but complained not enough frequency of education (90%). The sanitary status of the donated foods was considered as satisfactory but some safety practices had to be improved, including personnel expenses and operating costs in the district level, a sanitary awareness of the donors and a general management of the facilities arid equipment. An assessment on sanitary management resulted in an overall average of 4.45 out of 5 points in importance and 3.85 in performance showing the high level of sanitation perception in foodbank managers. From the IPA analysis, the fields found to be improved were sanitation management during cooking and temperature control as well as cleanliness and sanitation of both transport vehicle and refrigerator/freezer. To secure the food safety in foodbanks, consequently, personnel support, supplement of facilities and equipment, intense sanitation education and development of sanitation management program is needed.

Toxicity Assessment of Cyperi rhizoma Aqueous Extract Orally Administered to Rats for 13 Consecutive Weeks (랫드에서 향부자 추출물의 13주 반복 경구투여 독성평가)

  • Han, So-Ri;Han, Hyoung-Yun;Park, Heejin;Mi, Byung-Sun;Chung, Moon-Koo;Moon, Kyoung-Sik;Jeong, Ja Young;Roh, Hang-Sik;Seok, Ji Hyeon;Kim, Sang Kyum
    • YAKHAK HOEJI
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    • v.57 no.4
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    • pp.258-264
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    • 2013
  • Herbal medicine has been traditionally used in Asian countries for a long time. Many pharmacological effects are identified in the herbs and these herbs are believed to be safe for human. However, the safety or adverse effect of some traditional herbal medicines has not been established. We have chosen Cyperi rhizoma based on the Korea Herbal Pharmacopoeia and which have been widely used for an anti-inflammatory effect in Korea. The object of the study was to evaluate safety of Cyperi rhizoma in rats. The aqueous extract of Cyperi rhizoma was prepared according to the standard hot water extraction method of the Korea Pharmacopoeia. In the sub-chronic study, the aqueous extract of Cyperi rhizoma was orally administered once daily as 0, 125, 250, 500, 1000 and 2000 mg/kg/day to male and female F344 rats for 13 weeks. There were no treatment related abnormalities in mortality, clinical signs, food consumption, ophthalmologic examination, hematology, serum chemistry, urinalysis, gross observation, organ weight and histopathologic examination. In conclusion, The NOAEL (No Observed Adverse Effect Level) for Cyperi rhizoma aqueous extract was determined as more than 2000 mg/kg/day in the present experimental condition.

Breast-feeding and Obesity in Early Childhood - Based on the KNHANES 2008 through 2011- (영유아기 수유 유형과 모유 수유 기간에 따른 유아기 비만 양상 분석 - 2008~2011 국민건강영양조사 자료에 근거 -)

  • Yon, Miyong;Lee, Haeng-Shin;Kim, Dohee;Lee, Jeeyeon;Nam, Jiwoon;Moon, Gui-Im;Hong, Jinhwan;Kim, Cho-Il
    • Korean Journal of Community Nutrition
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    • v.18 no.6
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    • pp.644-651
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    • 2013
  • Although there has been a significant increase in breast-feeding (BF) rate in Korea, it is plateaued since 2008 and still low compared with that of other countries. Because BF has been related to lower obesity prevalence in many studies and the increase in childhood obesity became evident in Korea, we wondered if a relatively lower BF rate has anything to do with this increase. Therefore, we looked into the relationship between mode & duration of BF during infancy and weight status of toddlers using the data from Korea National Health and Nutrition Examination Survey 2008 through 2011. Number of 2-3 year old toddlers with complete information on BF, anthropometry and normal birth weight was 674. While 87% of them were ever-breastfed, 6.2% each of them were either obese or overweight based on the Standard Growth Chart for Korean Children. Not only the obesity prevalence was different among groups of different mode of feeding, but also the mean duration of BF was significantly longer in normal weight group (9.2 mo.) compared with obese group (5.5 mo.). Accordingly, overweight and obesity prevalence of the toddlers breast-fed for 12 months or longer was significantly lower than that of the toddlers breast-fed for less than 12 months (OR 0.53, 95% CI 0.32-0.87). This study revealed that both BF and duration of BF affect the childhood obesity and, BF for 12 months or longer should be encouraged more aggressively as one of the main strategies to prevent and/or decrease childhood obesity in Korea.

Monitoring of Lead and Cadmium Contents of Vegetables in Korea (국내 유통 중인 채소류의 납, 카드뮴 함량 모니터링)

  • Shim, Jee-Youn;Oh, Hyun-Suk;Jang, Mi-Ran;Lee, Yoon-Ae;Lee, Ryun-Kyung;Kim, Min-A;Lee, Hyo-Jung;Lee, Sang-Min;Cho, Tae-Youg
    • Journal of Food Hygiene and Safety
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    • v.25 no.4
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    • pp.395-401
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    • 2010
  • This research was carried out as a survey on the contents of Lead (Pb) and Cadmium (Cd) in 5 type agricultural products unestablished safety guideline in Korea. The average levels of Pb: onion 0.010 mg/kg, cucumber 0.018 mg/kg, garlic 0.012 mg/kg, green pepper 0.027 mg/kg, sesame 0.029 mg/kg. The average levels of Cd: onion 0.006 mg/kg, cucumber 0.002 mg/kg, garlic 0.008 mg/kg, green pepper 0.011 mg/kg, sesame 0.024 mg/kg. The present result of this study showed that Pb and Cd contents in the whole samples were less than the maximum residual levels of the codex standard. The levels of exposure assessment for Pb and Cd by intake from vegetables and sesame were merely at $1.3{\times}10^{-4}$(mean) ~ $5.1{\times}10^{-4}$($95^{th}$ percentiles) ${\mu}$g/kg bw/day for Pb, $7.5{\times}10^{-5}$(mean) ~ $3.6{\times}10^{-4}$($95^{th}$ percentiles) ${\mu$}g/kg bw/day for Cd. The data from this research will be valuable source for database construction for science-based safety control and management for the trace metal contamination in food including agricultural products.

Study on Development of Assessment Guideline and Endpoints for Clinical Trial with Antitumor Natural Products (천연물 항암제제 임상시험 평가지표 개발연구)

  • Namgung, Mi-Ae;Chang, Yoo-Sung;Jeong, Seung-Gi;Kim, Jin-Seung;Yoon, Sung-Woo;Jang, Ki-Young;Yoo, Hwa-Seung;Jung, Myeon-Woo;Lee, Sung-Ho;Kim, Sung-Hoon
    • Journal of Physiology & Pathology in Korean Medicine
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    • v.20 no.6
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    • pp.1678-1727
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    • 2006
  • This study was perfromed to develop the assessment guideline and endpoints for clinical trial with anticancer herbal medicine. The botanical products used to humans for long time may be applied to phase 3 clinical trial after submitting the evidences for safety and efficacy of them or completion of basic requirement of phase 1 and phase 2 for safety confirmation and dose determination. Syndrome improvement was chiefly evaluated by Zubrod and karnofsky(%) methods. We suggest the general clinical trial assessment with botanical products, by following assessment points, that is, tumor size for 50 points, survival fate for 10 points, major syndromes for 40 points. It is recommendable that the each symptom of Qi deficiency syndrome, blood deficiency syndrome and Qi stagnation syndrome was allocated by assessment points, Similarly, the each symptom was given the assessment points according to the severity of symptom, for example, slight for 3 points, moderate for 2 points and severe for 1 point in hepatocelluar carcinoma and lung cancer. Then, the efficacy of botanical products was evaluated by the difference between pre-treatment and post-treatment. Asking the neoplastic patients of questionnaire on physical, emotional, cognitive, social and role subjects availability, three more syndromes (Fatigue, Pain and Nausea/Vomit), quality of life(QOL) will be evaluated by GLM statistics. In addition, in case of lung cancer, 13 questions will be asked by the EORTC QLQ-C13 forms. As the assessment of endpoints for efficacy to reduce side effects induced by chemotherapy and radiotherapy, the data of image scanning and hemato-urinalysis can be usefully applied on immune response, weight loss, indigestion, hemopoietic damage and injury of liver and kidney, while the changes of syndromes of side effect can be evaluated by differentiation methods of Qi and blood and five viscera. However, it is still necessary to determine the ratio between scientific analytical method and Oriental differentiation method as well as confirm the Oriental assessment endpoints by clinical trial. In addition, we suggest the continuous development of assessment endpoints on other carcinomas except of hepatocelluar carcinoma and lung cancer in future.

Establishment of Sample Preparation Method for PCR Detection of Clostridium perfringens from Agricultural Products (PCR 법을 이용한 농산물 중 Clostridium perfringens 검출을 위한 전처리법 확립)

  • Choi, Song-Yi;Seo, Min-Kyoung;Yoon, Jae-Hyun;Rajalingam, Nagendran;Hwang, Injun;Kim, Se-Ri
    • Journal of Food Hygiene and Safety
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    • v.36 no.1
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    • pp.93-99
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    • 2021
  • This study was undertaken to compare the efficacy of different sample preparation (stomaching, pulsifying, and sonication) and DNA extraction methods (boiling and commercial kit) for detection of enterotoxin-producing Clostridium perfringens from produce by polymerase chain reaction (PCR). Each produce type was inoculated at concentrations of 102, 103, 104, 105, 106, and 107 spores/g. Produce inoculated with spores was treated with three sample preparation methods, and DNA was extracted by boiling method and a commercial kit, followed by PCR. The detection limit of stomached samples was lower than that of pummeled and sonicated samples by 10-100 times. Moreover, the DNA extraction efficiency of the commercial kit was found to be superior to that of boiling. In particular, the PCR efficiency of cherry tomato and perilla leaf samples was greatly affected by sample preparation and DNA extraction method. These data suggest that DNA extraction with a commercial kit after pulsification is an optimum sample preparation method for detection of C. perfringens by PCR.

Therapeutic Evaluation of a Topical Unani Formulation, Tila-i Muhāsā in Buthūr Labaniyya (Acne Vulgaris): A Randomized, Controlled Clinical Study

  • Azahar, Mohd;Uddin, Qamar;Kazmi, Munawwar Husain;Khatoon, Faiza;Husain, Nazim
    • CELLMED
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    • v.10 no.2
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    • pp.15.1-15.9
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    • 2020
  • Introduction: Buthūr Labaniyya (Acne vulgaris) is a multifactorial disorder of the pilosebaceous units characterized by non-inflammatory and inflammatory clinical lesions. Several Unani medications have been used for centuries to treat acne. Objectives: Evaluation of safety and efficacy of Tila-i Muhāsā in patients with acne vulgaris Materials and Methods: This clinical study was conducted in patients with acne vulgaris. Patients applied Tila-i Muhāsā or 5% Benzoyl Peroxide (BPO) once daily for 6 weeks. Assessment of efficacy was carried out by Global Acne Grading System (GAGS) and Patient Global Assessment (PGA) scores. In addition, overall severity of acne was evaluated on a 5-point Cook's acne grading scale using photographic standards. Assessment of safety was performed through adverse drug reactions, local dermal tolerability, vital signs, and routine laboratory investigations. Results: A total of 60 patients (30 in each group) completed 6 weeks of treatment. The mean percentage reduction in GAGS score at 6 weeks from baseline in Unani group (66.97%) and BPO group (59.09%) was statistically significant (P<0.0001). After 6 weeks of therapy, the mean percentage reduction in PGA score compared to baseline in Unani group (57.44%) and BPO group (50.23%) was statistically significant (P<0.0001). No serious adverse events were reported in both groups; however, mild adverse events occurred more frequently in BPO group (30%) compared to Unani group (10%). Conclusion: Tila-i Muhāsā was found to be effective and safe in the treatment of acne vulgaris. However, further clinical studies with larger sample size and longer duration of therapy need to be conducted.